Microtech, a medical device start up company and a sister company of Medinol, is hiring a QA and Documentation Control Specialist for a temporary position covering a maternity leave for approximately 7 months.
The QA and Documentation Control Specialist is responsible for maintaining the company’s quality management system and its documentation to meet established quality standards and release top of the line products.
Requirements:
- 1-3 years of experience in Quality function in Medical Devices company;
- Experience with QMS implementation that complies with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards
- Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
- Knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, 14971 (Risk Management) requirements- an advantage
- BS/BA in engineering or science discipline. Certificate in quality assurance is a plus.
- Detail oriented
- Good communication skills, both verbal and written
- Excellent English reading, writing and oral communication skills
Responsibilities:
Responsible for maintaining quality management system and activities including:
- Documentation control
- Review and approval of manufacturing records, and product release.
- Coordinate Company Training and implementation as required by the Quality management system
- Maintain calibration records and coordinate calibration activities
- Review and approval of test protocols and reports
- Development, performance and oversight of all routine QA activities according to applicable regulatory requirements.
- Ensuring compliance with regulatory and company procedure requirements.
- Supporting R&D in creation of documentation (DHF)
- Interface with Regulations, R&D, Operations and Product Management to implement appropriate verification activities and documentation supporting release of products
